Atrial Anomalies Predict Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Cryptogenic Stroke
Recruiting now · Not applicable
Conditions studied: Paroxysmal Atrial Fibrillation, Cardiac Rhythm Disorder, Left Atrial Dilatation, Cryptogenic Stroke
In brief
Cryptogenic stroke (CS) causes about 30% of admissions to a stroke unit. Silent paroxysmal atrial fibrillation (PAF) is believed to be the underlying cause of a significant proportion of patients. The use of implantable cardiac monitors (ICM) early after the CS has demonstrated benefits in the diagnostic yield, but the indication for ICM in the current guidelines remains unclear. Atrial contraction strain (ACS) evaluated by cardiac ultrasound could be of help to select the patients more prone to suffer from silent PAF. The purpose of this investigation is to conduct a randomized prospective unicentric study to evaluate the usefulness of ICM for early detection of silent PAF episodes in patients with CS. Clinical and ultrasound predictors of PAF occurrence (ACS) will be studied in order to define patients needing a closer follow-up.
Key facts
- Study ID
- NCT06542770
- Run by
- Parc de Salut Mar
- People needed
- 100
- Starts
- 2021-01-01
- Expected to finish
- 2024-12-01
- Last updated by the study team
- 2024-08-07
Who can join
Age: 50 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Acute ischemic stroke or transient ischemic attack (TIA) from January 2022 to July 2023
- Age between 50 and 89 years;
- Undetermined origin at hospital admission according to the SSS-TOAST criteria (2):
- Absence of major structural heart disease by cardiac ultrasound (normal global and segmental left ventricle contraction, absence of valvular/rheumatic disease, absence of intracardiac shunts)
- Absence of AF during 48h ECG-monitoring
- Absence of major anomalies in the supra-aortic trunks ultrasound.
You may not qualify if…
- Patients with a history of hemorrhagic stroke;
- Presence with prior atrial fibrillation or atrial flutter;
- Permanent contraindication or indication for OAC for other reasons;
- Recent (<1 month) major surgery or cardiac events;
- Presence of severe cardiac abnormalities;
- Patients with life expectancy <1 year or severe stroke (modified Rankin Scale > 4).
Where it is running
- Hospital del Mar — Barcelona, Spain (enrolling)
Full record on ClinicalTrials.gov
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